Regulatory failure leads to risks, expert says

(Photo Courtesy of Laura Stark)

Failing to get proper consent from parents in a study that potentially put babies at risk is unquestionably a regulatory failure and perhaps a moral failure, according to Laura Stark, an expert on medical regulation and ethics.

“This is a perfect but tragic example demonstrating that human-subjects regulations do not adequately address multi-studies,” said Stark, an assistant professor in the Center for Medicine, Health and Society. She has studied human-subjects regulation, Institutional Review Boards (IRBs) and the history of the National Institutes of Health ethics standards.

In the current case, the federal Office for Human Research Protections (OHRP) found that several universities involved in a study of oxygen levels for extremely premature babies failed to adequately inform families of the risks – mainly that increasing oxygen levels could potentially increase the chances of blindness or death. Twenty-three academic institutions took part in the study.

“The big take home lesson is that these multi- studies are a real problem because IRBs have a hard time dealing with them and that is because they don’t want to change the study materials, including consent forms. And this appears to be the problem — consent forms didn’t give parents the whole picture, particularly that death was more likely than they let on,” Stark said.

Institutional Review Boards at individual universities and hospitals involved in large, multi-institutional studies tend to “encourage boilerplate ethics” when questions arise about the adequacy of consent forms in large studies, she said. Substantially changing consent forms or other materials would delay the study, requiring approvals and changes at each institution.

No one wants to take responsibility for impeding the research, Stark said, and they rarely know when other institutions share their worries about a consent form. Additionally, the federal government doesn’t want to assume the legal responsibility of centralizing the process.

[lquote]“Right now the system is brilliantly legal because there’s really no one to blame.[/lquote] It’s just like the financial crisis because the responsibility is so diffused. It’s diffused not to people but to committees, and not to just one committee but 23 across the United States,” she said.

Stark spoke to the National Academies of Science on multi-site research in qualitative research in March 2013. The federal regulators who sanctioned the IRBs in the current case are now revising federal human-subjects regulations, she noted.

Stark has written a book, Behind Closed Doors: IRBs and the Making of Ethical Research, based on her yearlong observations of decision-making inside three IRBs, and on her historical research using previously unknown internal NIH records as a Stetten Fellow at NIH’s Office of NIH History.